• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F2 16MM; KNEE ENDOPROSTHETICS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AESCULAP AG ENDURO MENISCAL COMPONENT F2 16MM; KNEE ENDOPROSTHETICS Back to Search Results
Model Number NR883M
Device Problems Fracture (1260); Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); Implant Pain (4561)
Event Date 08/09/2020
Event Type  Injury  
Manufacturer Narrative
Investigation on going.Additional information / results will be submitted in a supplemental report.
 
Event Description
It was reported that there was an issue with enduro meniscal.According to the complaint description, it was reported that fracture of axis occured.Both axis and inlay changed.The primary implantation of the prosthesis was on (b)(6) 2012 in the (b)(6).The first inlay and axis revision due to suspicion of infection was on (b)(6) 2014, the second for the same reason on (b)(6) 2017, both in (b)(6).Now the third revision on (b)(6) 2020, the axis and the inlay changed, but the existing locknut was reused.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).
 
Manufacturer Narrative
Investigation results: visual investigation: the rotation axis has fractured above the taper, directly below the screw thread.The taper of the rotation axis shows little visible damage on the surface.The breakage surface of the larger distal part of the axis shows massive secondary damage.The device history records have been checked for all available lot numbers and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot numbers.On the basis of the current information, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the baisis of the device history records.We assume that the loosening of the rotation axis locking nut occurred prior to the breakage of the rotation axis.A root cause for the loosening of the nut could be that, when the connection between the axis taper and the femur was not firmly fitted, there is a gap and hence movement between the components.This leads to the femur safety nut unscrewing and then - as a consequence - to the axis breaking above the taper.The load transfer in this case is transmitted through narrowest part of the axis not through the main axis.Furthermore it could be possible that a special patient situation, for example disturbance in coordination lead to extreme bending moments and contribute a fracture.Based on the investigations and results of the 8d report no capa is necessary.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDURO MENISCAL COMPONENT F2 16MM
Type of Device
KNEE ENDOPROSTHETICS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key10563903
MDR Text Key208341739
Report Number9610612-2020-00490
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K101815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2022
Device Model NumberNR883M
Device Catalogue NumberNR883M
Device Lot Number52336148
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2020
Initial Date Manufacturer Received 08/26/2020
Initial Date FDA Received09/21/2020
Supplement Dates Manufacturer Received10/01/2020
Supplement Dates FDA Received10/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
-
-